التفاصيل البيبلوغرافية
| العنوان: |
Efficacy and safety of tivozanib in recurrent, platinum-resistant ovarian, fallopian tube or primary peritoneal cancer, an NCCN phase II trial. |
| المؤلفون: |
Cowan, Mathew1 (AUTHOR), Swetzig, Wendy M.1 (AUTHOR), Adorno-Cruz, Valery1 (AUTHOR), Pineda, Mario J.1,2 (AUTHOR), Neubauer, Nikki L.1 (AUTHOR), Berry, Emily1 (AUTHOR), Lurain, John R.1,2 (AUTHOR), Shahabi, Shohreh1,2 (AUTHOR), Taiym, Deanna2 (AUTHOR), Nelson, Valerie3 (AUTHOR), O'Shea, Kaitlyn Lucrezia4 (AUTHOR), Kocherginsky, Masha4 (AUTHOR), Matei, Daniela1,2,5 (AUTHOR) Daniela.matei@northwestern.edu |
| المصدر: |
Gynecologic Oncology. Oct2021, Vol. 163 Issue 1, p57-63. 7p. |
| مصطلحات موضوعية: |
*PERITONEAL cancer, *OVARIAN cancer, *VASCULAR endothelial growth factor receptors, *FALLOPIAN tubes, *PROTEIN-tyrosine kinase inhibitors, *ENDOTHELIAL growth factors, *OVERALL survival |
| مستخلص: |
Tivozanib is a potent selective pan-vascular endothelial growth factor receptor tyrosine kinase inhibitor with a long half-life. This study assessed its activity in patients with recurrent, platinum-resistant ovarian, fallopian tube or primary peritoneal cancer (OC). This open-label phase II study used a Simon's two-stage design. Eligible patients had recurrent, platinum-resistant OC and measurable or detectable disease. There was no limit on the number of prior regimens. Treatment consisted of tivozanib 1.5 mg orally once daily for 21 days in a 28-day cycle. The primary endpoint was objective response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and toxicity assessment. Thirty-one patients were enrolled, and 30 were treated. The median age was 59.5 years, and median number of prior regimens was 4 (range 1–9). Twenty-four patients were evaluable for response, and four (16.7%) achieved a partial response (PR; ORR = 16.7%). An additional fourteen (58.3%) patients had stable disease (SD). The clinical benefit rate (PR + SD) was 75.0%, and the median duration of objective response was 5.7 months. For all patients on trial, the median PFS was 4.1 months (95% confidence interval (CI): 1.7–5.8) and OS 8.6 months (95% CI: 5.4–12.5). There were no treatment-related deaths. Serious adverse events occurred in 13.3% of patients and included small intestinal perforation or obstruction and stroke. Grade 3–4 adverse events occurred in 60% of patients, including hypertension (26.7%) and fatigue (10%). Tivozanib is effective in patients with recurrent OC, with moderate toxicity and no treatment-related deaths, supporting its further development. • Tivozanib is a potent vascular endothelial growth factor receptor tyrosine kinase inhibitor. • Response rate to Tivozanib in platinum-resistant ovarian cancer is 16.7%; median progression-free survival is 4.1 months. • The most common adverse events were fatigue and hypertension. [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
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